Instructions For Use
- Manuals are subject to change; the most current version is always available on this site.
- Manuals for all products may not be available on this site. If you do not find the manual you seek, please contact your APEX Biologix sales representative.
- CAUTION: Federal Law restricts the device to sale by or on the order of a physician.
- CAUTION: The XCELL PRP Platelet Concentrating System 60ml (XC-PRP-60) is provided sterile. DO NOT use any component of the system if the packaging is opened or damaged. DO NOT clean and/or re-sterilize. Single-use only.
COMPANY INFO: APEX Biologix is a medical device and biologics company that markets products in the fields of interventional pain management, sports medicine, and orthopedics. An industry leader, APEX Biologix provides comprehensive tools to help practitioners become successful in these disciplines.
INDICATIONS FOR USE: The XCELL PRP™ System is intended to be used for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to the application to a bony defect for improving handling characteristics.
CONTRAINDICATIONS: The XCELL PRP™ Platelet Concentrating System may be contraindicated when used in a non-sterile environment, patients taking aspirin within 72 hours, drugs that affect platelet function, patients with any serious medical conditions that would make the subject unable to safely tolerate the extracorporeal blood components and/or volume required for the procedure. The blood products from this device are not to be used for transfusion.
WARNING AND PRECAUTIONS:
- Appropriate precautions should be taken to protect against needle sticks.
- Do not use the components in the XC-PRP-60 kit if the packaging is open or damaged.
- Do not use after expiration date.
- Use only the Instruction for Use of the XC-PRP-60 system.
- The physician and all staff who will be utilizing the XC-PRP-60 should be well versed in the use of the system, ancillary equipment, maintaining a sterile environment, trained phlebotomists, disposal of biohazards, etc.
- The PRP sample should be used within 4 hours of blood draw.
- The PRP is not intended to be returned to the patient’s circulatory system.
- The XC-PRP-60 system is single use. DO NOT clean or re-sterilize any part of this system. Dispose of all components immediately after procedure is complete, with special attention to placing needles in sharps containers immediately after use.
- Venipuncture, collection and platelet harvest process of the patient’s blood should occur under aseptic conditions. The disposable XCELL PRP™ Platelet Concentrating System, syringes and accessories, must be properly discarded following standard biohazard guidelines after each use. Sealed sterile packages containing the XCELL PRP™ Concentrating Device and accessories must be inspected before opening. If seal is broken, contents may not be sterile.
- The patient should be informed of the risks associated with whole blood aspiration which include, but are not limited to, hemorrhage, thrombosis formation, infection, and/or persistent pain at the site of aspiration.